EVALUATION OF VTMs
Last updated: 19 March 2021

The Research Institute for Tropical Medicine (RITM), as the National Reference Laboratory, is mandated to perform the evaluation of commercially-manufactured in vitro diagnostic medical devices, in collaboration with the Philippine Food and Drug Administration (FDA).

The huge increase in testing has put pressure on the laboratory supply chain and resulted in shortages of viral transport media (VTM). In support of the national COVID-19 response, the Institute has undertaken evaluation of laboratory test kits as well as VTM and swabs.

Evaluation of the VTM is done by infecting the swabs with known Influenza A and Influenza B clinical samples and is subsequently submerged into the VTM. The VTM is tested in parallel with commercially available swab/VTM combinations (reference kit) for Real-time PCR detection of Influenza following WHO recommended protocol. Acceptability of the product is dependent on the generated PCR values if comparable with the reference kit.

Read more about the guidelines on the evaluation of in vitro diagnostic medical devices and other related laboratory diagnostic supplies for COVID-19 here.

results

Results of RITM evaluations do not, in any way or form, represent a Certificate of Product Registration or Certificate of Authorization issued by the Philippine Food and Drug Administration (FDA).

The Institute is making this information available for public good and does not serve to endorse companies, manufacturers, or product brands for commercial purposes.